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Efficacy and Safety of Basiliximab in Hepatitis C Virus Positive Patients Undergoing Liver Transplantation

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00238901
First received: October 12, 2005
Last updated: August 31, 2010
Last verified: August 2010
History of Changes
  Purpose

The natural history of HCV infection in liver transplant recipients may be accelerated when compared to that in patients with normal immune systems.

The objective of this trial is to assess the efficacy and safety of basiliximab, in combination with cyclosporin and MMF on the success rate of liver transplants for HCV related cirrhosis, in comparison with standard steroid treatment.


Condition Intervention Phase
Liver Transplant
 Drug: Basiliximab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Basiliximab in HCV+ Patients Undergoing Liver Transplantation, as Compared With Steroids, Both Given in Combination With Cyclosporine and Mycophenolate Mofetil (MMF)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 12-month cumulative incidence of post-surgical graft loss and death

Secondary Outcome Measures:
  • hepatitis C recurrence (see definition 3.5.2) at 6 and 12 months after transplant surgery.
  • treated and biopsy proven acute rejection at 6 and 12 months after transplant surgery.
  • graft survival and patient survival after treatment with either Simulect or steroids at 6 and 12 months.
  • viral load (HCV-RNA) after treatment with Simulect or steroids at Baseline, Month 1 and 3 post transplantation.

Enrollment: 194
Study Start Date: December 2002
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria Patients undergoing first cadaver liver transplant Patients receiving an AB0 identical or compatible graft HCV+ patients (serology test within the last 12 months)

Exclusion Criteria Antiretroviral prophylactic treatment post-transplant Serological markers positive for Hepatitis B surface Antigen and Human Immunodeficiency Virus Recipients of a split liver transplant Other protocol-defined inclusion/exclusion criteria applied

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238901

Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00238901     History of Changes
Other Study ID Numbers: CCHI621AIT06
Study First Received: October 12, 2005
Last Updated: August 31, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Novartis:
Liver transplant, HCV+, steroid free

Additional relevant MeSH terms:
Mycophenolate mofetil
Basiliximab
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013